- Genmab (Plainsboro, NJ)
- … trial specific Clinical Trial Teams (CTT) to deliver clinical trials including managing the trial budget. The GCTM is accountable ... authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for...for the end-to-end delivery of a single or multiple clinical trials from strategy outline through to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations (NACO) Manages and communicates financial status of ongoing clinical trials , including identification of variance and risks. Identifies ... mitigations and develops new forecasts as required Ensures that clinical trial budgets remain on track and...technical, regulatory, and legal terminology of contracts, preferably in clinical trials Must work with minimal direction.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... of the study; Identify issues and propose solutions.Responsible for ensuring that the Clinical CRO (s) provide timely input and generate documents in a timely… more
- Genmab (NJ)
- …management activities and processes support the efficient and effective execution of clinical trials .Ensures trial related data management activities ... and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM...all aspects of data management.Experience within all phases of clinical trials .Experience with clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the...( CRO ) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …application of those principles to trial design, planning & conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or ... external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs...who contribute to the planning, conduct and reporting of clinical trials . Ensures business needs are met… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …performance indicators to support vendor/ CRO oversight of CRAs in clinical trials .Contribute to KPI/metric development in collaboration with Strategic Vendor ... Monitoring Oversight and Excellence and the CSOP as it relates to monitoring and CRO /vendor oversight. This is a highly collaborative and dynamic role within a fast… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …similar environment (eg, CRO ) requiredOncology, immunology, or complex disease clinical trial experience preferredMust have a strong understanding and ... knowledge of MedDRA, and WHO not DD is requiredWorking knowledge of Clinical trial data systems and/or EDC coding tools is a preferred Daiichi Sankyo,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to support drug development processes and global submissions as required for clinical trials . These include developing and validating SAS programs for ... clinical trials . This position will work closely...5 years (w/BS) or 4 years (MS) SAS and clinical programming experience in the biotech/pharmaceutical/ CRO industry… more
- Digital Prospectors (Palo Alto, CA)
- …higher) in a science or health-related field. + 7+ years of clinical trial experience within a pharmaceutical, biotech, or CRO environment, with a preference ... **Senior Clinical Trials Manager** **Palo Alto, CA**...and approving them based on the approved budget. + Control and manage trial -related expenses according to… more
- Pennsylvania State University (Hershey, PA)
- …at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Monitor. The Beat Childhood Cancer Research Consortium (BCC) is ... of 50+ hospitals across the US and Canada that participate in BCC's investigator-initiated clinical trials . This job does require travel to BCC hospital sites… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials , across all therapeutic areas, around the world. In partnership with ... Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable… more
- University of Rochester (Rochester, NY)
- …RESPONSIBILITIES: - Directs the development and execution of clinical trial activities for multi-center industry sponsored drug trials , including developing ... all aspects of multi-center international clinical research trials in a Contract Research Organization ( CRO )...sites, vendors and sponsor. Oversees entire study team, including clinical trial sites (average 20 per … more
- University of Rochester (Rochester, NY)
- …department. The Medical Director serves as a key clinical resource for Clinical Trials clients (Pharmas, CRO 's, Medical Centers) in particular ... of the Department of Pathology and Laboratory Medicine the Clinical Trials Medical Director is responsible for...Trials specific technical procedures and reviews all current Clinical Trial -specific procedures on an annual basis.… more
- Actalent (Philadelphia, PA)
- …Management. + Oversee trial feasibility and site identification activities, monitor clinical trial performance and quality metrics, and ensure actions are ... Job Title: Lead Clinical Study Manager Job Description The Lead ...amendments, including additional medical writing tasks. + Lead the CRO and vendor selection process and create the … more
- University of Rochester (Rochester, NY)
- …Manager assists with coordinating all aspects of multi-center clinical research trials in a Contract Research Organization ( CRO ) environment. This individual ... serves as a liaison with clinical trial sites to address protocol questions... Research Manager, coordinates study activities for large multi-site clinical trials within the Clinical … more
- Pennsylvania State University (Hershey, PA)
- …across the US and Canada that participate in BCC's investigator-initiated clinical trials . This position supports clinical trial research across these ... College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Coordinator. The Beat Childhood...study participants based on inclusion/exclusion criteria onto active BCC clinical trials from participating study sites. +… more
- ThermoFisher Scientific (Suwanee, GA)
- …a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of ... research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver...Medic will provide medical support and medical advice for clinical trials and safety evaluation to PPD… more
- Pennsylvania State University (Hershey, PA)
- …across the US and Canada that participate in BCC's investigator-initiated clinical trials . This position supports clinical trial research across these ... Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Coordinator. The Beat Childhood Cancer Research Consortium (BCC) is an… more
